Clinical Evaluation of Two Daily Disposable Lenses in Sphere Design

Coopervision, Inc.1 site in 1 country41 target enrollmentAugust 8, 2022

ConditionsAmetropia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ametropia
Sponsor: Coopervision, Inc.
Enrollment: 41
Locations: 1
Primary Endpoint: Lens Fit Acceptance
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.

Detailed Description

The aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (DDH) when compared to daily disposable silicone hydrogel lens (DDSH) after 15 minutes of daily wear each.

Registry

clinicaltrials.gov

Start Date

August 8, 2022

End Date

October 12, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Coopervision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Is at least 18 years of age and has full legal capacity to volunteer.
•Has read and signed an information consent letter.
•Self-reports having a full eye examination in the previous two years.
•Anticipates being able to wear the study lenses for the required time of the study.
•Is willing and able to follow instructions and maintain the appointment schedule.
•Has refractive astigmatism no higher than -0.75 DC.
•Can be fit with the available lens parameters (sphere +8.00 to -10.00D).
•Can achieve binocular distance vision of at least 20/30 Snellen (logMAR 0.18) with the study contact lenses.

Exclusion Criteria

•Is participating in any concurrent clinical or research study.
•Has any known active ocular disease and/or infection that contraindicates contact lens wear.
•Has a systemic condition that in the opinion of the investigator may affect a study outcome variable.
•Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable.
•Has known sensitivity to the diagnostic sodium fluorescein used in the study.
•Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment.
•Has undergone refractive error surgery or intraocular surgery.

Outcomes

Primary Outcomes

Lens Fit Acceptance

Time Frame: 15 minutes

Measured on a scale of 0-4 (0 = Should not be worn, 1 = Borderline but unacceptable, 2 = Min. acceptable, early review, 3 = Not perfect but OK to dispense, 4 = Perfect) as assessed by an investigator.